adult and child hands holding red heart, organ donation concept image.

Opt-in vs. Opt-out Organ Donation Schemes: Evidence from the US and UK

By James W. Lytle

We need to encourage organ donation. In the U.S. alone, even with a record number of about 40,000 transplants in 2019 and some progress made towards closing the gap, approximately 108,000 Americans are on the waiting list.

In considering the best way to increase organ donation, much of the debate has focused on how to make organ donor registries more successful: nothing facilitates the prospect for organ donation more than knowing that a potential donor has already indicated their intention to donate.

Should registries, like those in the U.S., require people to elect to join (the “opt-in” approach) or should they presume consent to organ donation and register everyone except those who explicitly “opt-out,” as is the case in certain other countries?

I asked two transplant professionals, one from the U.S. and one from Wales, to help consider this question and related issues involving organ donation.

James Lytle: First, to Phil Walton, the Project Lead for Deemed Consent Legislation with the National Health Service Blood and Transplant Division. You are working on the recent implementation of the “deemed consent” or “opt-out” registry in Wales and in England: can you provide us with some background on what led to the change in policy and how the deemed consent process works?

Phil Walton: The situation in the U.K. is similar to that in the U.S., with the number of people waiting on the transplant list exceeding the numbers of donors and subsequent transplants available. Though some progress has been made, the disparity continues to this day.

Wales has had an opt-out system since 2015, but much of the work to deliver that started back in 2011. At that time, the Health Minister for Wales understood that more than 90% of the Welsh population supported organ donation, and yet the opt-in rate fell well below 50%. A public consultation to the Welsh people received encouraging feedback about the idea of introducing an opt-out system. Work began to draft the legislation, which became an Act in 2013, allowing a two-year window for preparations.

The English Department of Health and Social Care kept a watchful eye on the progress in Wales, and determined that England should follow suit. Two years and 13 Parliamentary stages later, we finally had the Organ Donation (Deemed Consent) Act of 2019, which was brought into force on 20th May 2020.

In both countries, the deemed consent process is very similar. All adults living in England or Wales are considered willing to be a donor unless they opt out or are in one of the excluded groups, which are:

  • Under 18 years
  • Not ordinarily a resident of England or Wales
  • Lacking the mental capacity to understand the law (for a full 12 months prior to death)
  • Already have a donation decision in place

In the U.K. we have one Organ Donor Register (ODR), which captures both opt-ins and opt-outs. If there is no ODR registration and the family of a recently deceased individual are not aware of a donation decision, deemed consent can be applied. If the inclusion criteria are met, the family will be asked to support the deemed consent of their loved one.

JL: What have been the results so far?

PW: In May 2020 we published in Anesthesia the findings from a study we conducted in NHSBT which tracked the progress of consent in Wales during the first three years following the implementation of deemed consent.

The study found a statistically significant increase (10% or more) in consent for Donors after Brain Death (DBD) in Wales compared to England (which, at the time was an opt-in country).

For England, we are only six months into this long-term behavior change strategy. However, preliminary data show an encouraging start to the implementation and embedding of the new law.

By way of comparison, where there was no registration from the potential donor and the absence of a known decision, the consent rate would normally sit at 50%. However, this scenario can now fall into the deemed consent category, for which (at six months post-implementation) the consent rate for these cases currently sits at 71%. The Welsh experience demonstrates a delayed impact of the legislation, and so we use these data with caution, but are encouraged by this as a baseline.

JL: Turning to you, Alexandra Glazier, the President/CEO of the New England Donor Services, which is responsible for organ procurement for a population of 14 million people in six states. Can you first describe the organ registry process in the U.S. — how does it work here?

Alexandra Glazier: Understanding the donor registry process in the U.S. starts with understanding the legal framework for the donation of an organ from one individual to another. This process is governed by the Uniform Anatomical Gift Act (UAGA), which is based on gift law, and not informed consent principles.

This is key to understanding why the opt-in donor registry system of donation works so well here. Gift law allows for a very simple process of opting in — for example, at the time that you renew your license, online at, or on your iPhone in about 30 seconds through the Health app. This process legally authorizes a gift after death; it’s not an informed consent process, it’s not designed to be one, and is not required to be one, consistent with the UAGA.

When a registered donor dies in a manner that allows for organ donation, the registration constitutes legal authorization for donation to proceed without any further permission from family.

JL: What do you see as the advantages of the “opt-in” approach?

AG: Ultimately the advantage to an opt-in approach for the U.S. is that it is both well-aligned culturally with our prioritization of individual autonomy and it is effective, facilitating one of the highest donation and transplant rates in the world.

However, the U.S. is not yet meeting the need. So, while our system outperforms almost every other country, we have to continually seek to do better. Would opt-out do better in the US?

The rationale often cited for an opt-out framework is threefold: (1) an assumption that it will, in fact, increase donation; (2) the view that opt-out policies bridge the gap between intent and action, meaning that setting up a default like this will capture those individuals who aren’t moved to register, but would like to become organ donors; and (3) the potential signaling effect, in other words, the idea that an opt-out approach would normalize organ donation, which alone would be beneficial.

The data simply do not support better overall deceased donation performance for jurisdictions with opt-out policies versus opt-in. In international comparisons, the U.S., with its opt-in system, is second only to Spain in donation (with several US states outperforming Spain). And in 2019, the U.S. and Spain both recorded 109 deceased donor transplants per million population — the highest rate in the world.

In a JAMA article, we reviewed data showing that legal jurisdictions with opt-out overall have a 27% lower mean donation rate than the jurisdictions that have opt-in. Spain, like Wales and most other presumed consent jurisdictions, ultimately requires family permission, essentially removing the full potential impact of the opt-out legal default. This may, in part, explain the seemingly counter-intuitive result that opt-out systems do not outperform opt-in systems.

And the opt-in system of donation does, in fact, provide a mechanism to bridge the gap between intent and action, by providing two pathways to obtain a “yes” to organ donation. An individual can register as a donor, or, if an individual hasn’t make a donation decision, the family/surrogate can be approached by organizations like mine at the time of death, if there is a clinical opportunity for organ donation to happen. The difference is, the opt-in system prioritizes the individual’s actions to be a donor — if the patient is a registered donor, family permission is not sought and family objection is not a barrier to proceeding. Compare this to most opt-out systems, where family permission is nonetheless sought and/or family objection prevents the donation from proceeding.

The culture here within the U.S. is particularly well-aligned with opt-in donation policies and practices. Americans simply don’t want the government deciding to take their organs without asking. Think about what has happened during the pandemic with a public health directive for people wear masks for their own benefit as well as the benefit of other’s health and wellbeing.

Thus, while the rationale for considering moving to opt-out system is well intentioned, it could actually result in a drop in the U.S. donation rate. There are no examples of a country performing at the level of the US switching to opt-out and experiencing improved performance.

JL: Alex, a variation on “opt-in” is referred to as “mandated choice,” which would require, for example, that the customer at the motor vehicles office must answer the question — one way or the other — in order to complete their transaction: what do you think of that approach?

AG: A variation on this approach is already in place in the U.S. The U.S. donor registry system is what Professor Cass Sunstein calls “prompted choice”; when you go to renew your license in the vast majority of states, you will, in fact, be required to answer the question of whether you want to register as a donor. A “yes” will put your name in the donor registry and constitute authorization for donation under the law at the time of death. A “no” will result in you not being included in the donor registry.

This choice architecture (to use Sunstein’s term) is better than “mandated choice” because it provides an easy opportunity to say yes to donation without the forced binary framework of a legal refusal to donation, which would preclude approaching a surrogate/family at the time of death. Not registering as a donor is not the same as refusing to be a donor. It simply is understood under the law as no decision at all, which will enable family/surrogates to be approached and potentially authorize donation at death. This is one of the key ways the U.S. law and opt-in donor registry work together in a framework that maximizes authorization for donation.

James W. Lytle

Jim Lytle is Senior Counsel in the Albany and Boston offices of Manatt, Phelps & Phillips LLP, a national law and consulting firm. He is also currently a Senior Fellow with the Advanced Leadership Initiative at Harvard University and an adjunct professor at New York University Law School. He has provided health law and governmental relations representation to a broad array of clients in the fields of healthcare and human services, education and cultural affairs, insurance, biomedical research, and economic development. He has been recognized by Chambers USA as a Leading Lawyer since 2011 and was included in Best Lawyers in America since 2013, where he was named Best Lawyer of the Year in Albany for Health Law in 2017 and for Government Relations Law in 2017 and 2020. He served as Assistant Counsel for Health and Human Services for Governor Mario M. Cuomo, was the founding director of the Volunteer Legal Services Project in Rochester, NY and began his legal career as an Assistant District Attorney in Manhattan. He graduated from Princeton University in 1974 and received his JD from Harvard Law School in 1978, where he was the Director of the Harvard Legislative Research Bureau. He is a former Chair of the Health Law Section of the New York State Bar Association, the co-President of the Hermann Biggs Society and is a board member of the Schuyler Center for Analysis and Advocacy and of DonateLife New York.

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